REQUEST FOR:
(Select one)
Full Review
Expedited Review
Exempted Review
NEWMAN UNIVERSITY
APPLICATION FOR PROJECT/PROPOSAL APPROVAL
INSTITUTIONAL REVIEW BOARD (IRB)
Please use this Microsoft Word template to complete this form.
Name of Principal Investigator(s):
(For a student project, Principal Investigator must be a NU faculty member; student is listed as Co-Investigator.)
Departmental/Program Affiliation:
Campus Address:
Phone:
Name of Co-Investigator(s)
Co-Investigator is:
Faculty Member
Graduate Student
Undergraduate Student
Type of Project:
Class Project
Other
Capstone Project
Thesis or Dissertation
If student project, address of student
Title of Project/Proposal:
Expected Completion Date:
1. A brief description of the research in non-technical language:
2. A description of the benefits of the research to the human subjects, if any, and of the
benefits to human or scientific knowledge:
3. A description of the subjects, how the subjects are to be selected, how many are to be
used, and indicate explicitly whether any are minors (under age 18 per Kansas law ) or
otherwise members of "vulnerable" populations, e.g., prisoners, elderly, handicapped,
etc.:
4. A description of how the subjects will be used:
5. A description of the risks and discomforts, if any, to the subjects. Risks or discomforts
may be physical, psychological, or social. Some research involves neither risks nor
discomforts but rather violations of normal expectations of daily life. Such violations, if
any, should be specified:
6. A description of the means to be taken to minimize each risk or violation, including the
means by which the subject's personal privacy is to be protected and confidentiality of
information received maintained (e.g., disposition of questionnaires, interview notes,
recorded audio or videotapes, etc.):
7. If a waiver of written informed consent is desired, a justification of the request:
8. A copy of any consent form that is to be used with the subjects, including a line for signature
and date, must be attached. The consent form is to be placed on NU departmental
letterhead. Consent forms must be retained for three years.
9. Any other information pertaining to the researcher's ethical responsibilities to the
subjects:
10. Any questionnaire or survey forms used for actual administration or as guides for interviews
must be attached.
The Principal Investigator agrees to abide by the federal regulations for the protection
of human subjects and to maintain raw data (including audiotapes and videotapes) and
consent forms for a minimum of three (3) years beyond the completion of the study. If
the data collection or testing of subjects is to be performed by student assistants, the
Principal Investigator will assume full responsibility for supervising the students to
ensure that human subjects are adequately protected.
___________________________________________
Signature of Principal Investigator
___________________
Date
Note: Researchers, these three pages provide information about how to create a consent form for
participants to sign prior to participation in your study. A model is provided. Your consent form
should be constructed to meet the needs of your study.
CONSENT FORM
(Please put on NU Departmental Letterhead)
You are invited to participate in a study of (STATE WHAT IS BEING STUDIED). I/we hope to learn
(STATE WHAT THE STUDY IS DESIGNED TO DISCOVER OR ESTABLISH). You were selected as
a possible participant in this study because (STATE WHY AND HOW SUBJECT WAS SELECTED).
If you decide to participate, you will (DESCRIBE THE PROCEDURES TO BE FOLLOWED,
INCLUDING THEIR PURPOSES, HOW LONG THEY WILL TAKE, AND THEIR FREQUENCY.)
(DESCRIBE ANY RISKS, DISCOMFORTS AND INCONVENIENCES THAT MAY REASONABLY
BE EXPECTED, AND ANY BENEFITS TO SUBJECTS OR SOCIETY THAT MAY REASONABLY
BE EXPECTED.)
Any information obtained in this study in which you can be identified will remain confidential and will be
disclosed only with your permission. (IF YOU WILL BE RELEASING INFORMATION TO ANYONE
FOR ANY REASON, YOU MUST STATE THE PERSONS OR AGENCIES TO WHOM THE
INFORMATION WILL BE GIVEN, THE NATURE OF THE INFORMATION TO BE GIVEN, AND
THE PURPOSE OF THE DISCLOSURE.)
(DESCRIBE ANY COMPENSATION OR COSTS RELATED TO PARTICIPATION IN THE
STUDY.)*
Participation in this study is entirely voluntary. Your decision whether or not to participate will not affect
your future relations with (INSTITUTION OR AGENCY). If you decide to participate, you may
withdraw from the study at any time without affecting your status (AS A PATIENT, STUDENT, ETC.).
If you have any questions about this research, please ask me. If you have additional questions during the
study, I will be glad to answer them. You can contact me at: (NAME, ADDRESS AND PHONE).**
You will be offered (given) a copy of this consent form to keep.
You are making a decision whether or not to participate. Your signature indicates that you have read the
information provided above and have voluntarily decided to participate.
_____________________________________________________________
Signature of Subject
_________________
Date
_____________________________________________________________
Signature of Parent or Legal Guardian
(omit for subjects consenting for themselves)
_________________
Date
_____________________________________________________________
Signature of Investigator
_________________
Date
*For research posing more than minimal risk, and/or involving physical activity, see the next page.
**See note on the next page for information for mail-out questionnaire.
* If participation of human subjects poses more than minimal risk, and/or involves physical
activity, you must include the following paragraph:
I have been informed and I understand that Newman University does not provide
medical treatment or other forms of reimbursement to persons injured as a result of or
in connection with participation in research activities conducted by Newman
University, its faculty, or its students. If I believe that I have been injured as a result
of participating in the research covered by this consent form, I should contact the
Office of Academic Affairs, Newman University.
** If you are collecting data by means of a mail-out questionnaire, you may substitute the
following format from paragraph 7 through the end of the document (see ** previous
page):
You are under no obligation to participate in this study. Your completing and
returning this questionnaire will be taken as evidence of your willingness to participate
and your consent to have the information used for purposes of this study.
You may keep this cover letter and explanation about the nature of your participation
in this study and the handling of the information you supply.
Sincerely,
__________________________________________
Name of Investigator
NOTE: This letter must be signed by Principal Investigator.
GENERAL CONSENT FORM CHECKLIST FOR YOUR CONSIDERATION
ITEMS
1. Is the general purpose of the study stated;
what the researcher expects to learn?
2. Is the subject’s right to choose to participate
indicated?
3. Is there a statement indicating why and how
a subject was selected as a possible participant?
Are the population and number of subjects
identified?
4. Are the procedures to be followed in the study
clearly described (time, frequency, nature of
information asked, observations, etc.)?
5. Is there a statement of possible risks, discomforts
or inconveniences that the participants may
reasonably expect?
6. Are any substantial or likely benefits to subjects
identified?
7. Is there any standard treatment withheld or
alternative procedures available disclosed?
8. Is subject confidentiality explained?
(Use of tapes, photos, data, etc.)
9. Are subjects’ compensation and costs of
participating in the study identified?
10. Is where the subject can contact the investigator
to have questions answered indicated?
11. Is the subject’s right to a written copy of the
consent form stated?
12. Is there a statement that expresses that the
individual’s signature indicates a willingness
to participate?
13. Are the appropriate signature and date spaces
included?
Yes
No
Comments
Appendix
FULL REVIEW
Full committee review is required for all research involving greater than minimal risk to subjects.
In addition, full review is required for all research activities involving vulnerable subject
populations, including fetuses, pregnant women, human in vitro fertilization, prisoners, children,
elderly, and psychiatric patients.
Submit ONE copy of the research protocol, consent form, and abstract of your research proposal.
EXPEDITED REVIEW
Expedited review is provided for research which involves no more than minimal risk or for
review of minor changes in previously approved research protocols. In order to approve research
covered by the regulations, an IRB subcommittee will determine that all of the following
requirements are satisfied. (The list below is utilized for all projects under IRB review):







risks to subjects are minimized;
risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects,
and the importance of the knowledge that may reasonably be expected to result;
selection of subjects is equitable;
informed consent will be sought from each prospective subject or the subject’s legally
authorized representative;
informed consent will be appropriately documented;
when appropriate, the research plan makes adequate provision for monitoring data
collected to ensure safety of subjects; and
when appropriate, there are adequate provisions to protect the privacy of subjects and
to maintain the confidentiality of data.
Submit ONE copy of the application (this form, the research protocol, and consent form) and
identify the reason(s) for expedited review by encircling one or more numbers below The list
includes research with human subjects that involves:
1. Collection of hair and nail clippings in a nondisfiguring manner; deciduous teeth; and
permanent teeth if patient care indicates a need for extraction.
2. Collection of excreta and external secretions.
3. Recording of data from subjects 18 years of age or older using noninvasive procedures
routinely employed in clinical practice.
4. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in
an eight week period and no more often than two times per week, from subjects 18 years
of age or older and who are in good health and not pregnant.
5. Collection of both supra-and subgingival plaque and calculus provided the procedure is
not more invasive than routine prophylactic scaling of the teeth and the process is
accomplished in accordance with accepted prophylactic techniques.
6. Voice recording made for research purposes, such as investigation of speech defects.
7. Moderate exercise by healthy volunteers.
8. Study of existing data, documents, records, pathological specimens or diagnostic
specimens.
9. Research on individual or group behavior or characteristics of individuals, such as studies
of perception, cognition, game theory, or test development, where the investigator does
not manipulate the subject’s behavior and the research will not involve stress to subjects.
10.Research on drugs or devices for which an investigational new drug exemption or an
investigational device exemption is not required.
EXEMPTED REVIEW
There are several cases which may “exempt” your protocol from full IRB review. If you request
an exemption, you need to submit ONE copy of the application (this form and the protocol) and
identify the exemption by encircling one or more numbers.
The following categories are exempt from full review:
1. Research involving normal educational practices;
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey or interview procedures or observation of public behavior, unless the obtained
information is recorded in such a manner that human subjects can be identified;
3. Research involving the use of education tests (cognitive, diagnostic, aptitude, achievement),
survey or interview procedures, or observation of public behavior that is not exempt under (2)
if the subjects are elected or appointed officials or candidates for public officials, or federal
statutes require without exception that the confidentiality of the personally identifiable
information be maintained throughout the research and thereafter;
4. Research involving the collection of study of existing data, documents, records, or
pathological or diagnostic specimens if these sources are publicly available, or if the
information is recorded in such a manner that subjects cannot be identified;
5. Research and demonstration projects that are conducted by or subject to the approval of
department or agency heads, and which are designed to study, evaluate or otherwise examine
public benefit or service programs; and
6. Taste and food quality evaluation and consumer acceptance studies.